In such fields, the products must comply with stringent preservation standards in relation to the proliferation of microbes. One of the methods for ensuring this preservation is to include preservation agents in the product. However, these preservation agents may be badly tolerated by the user, and it is preferable to propose products which do not contain additives of this type, but which nevertheless have an adequate preservation period and microbial cleanliness. This objective can be achieved by sterilization of the products, and preservation of them in conditions which can maintain this sterility.
The sterility of a product is defined here in a manner which in itself is conventional, according to standard EN 556 and the European pharmacopeia in force, as the probability of a microorganism proliferating in the product. Typically, this probability is less than 10−6. According to standard ISO 13408 concerning the sterile production of health products, the sterile product must have been treated by means of a sterilization method, the sterilization value F0 of which must be more than 15 minutes. This value F0, the method for determination of which is defined by the European pharmacopeia in force, gives a time expressed in minutes which quantifies the lethal effect of humid heat at 121° C. on viable microorganisms. A product which is sterile according to the European pharmacopeia has been subjected to a sterilization process, the sterilization value F0 of which is equal to at least 15 minutes.
During their production or packaging, sterile products frequently have to be transferred from a first sterile container which contains them, into a second container which is also sterile, in particular for their temporary storage, or in order to distribute them between different packaging lines. It is then essential for transfer of this type to take place in conditions which make it possible to maintain the sterility of the product during its path from the first container to the second container.
Conventionally, the means which are used for transfer of this type consist of isolators provided with special doors, known as STDDs (Sealed Transfer Door Devices), such as the one described in patent application EP 1 067 089. These devices require an environment which is controlled and monitored from the microbiological point of view, and the transfer is thus implemented in a sealed enclosure, the internal atmosphere of which is kept sterile, thus involving in particular renewal of its internal air volume and absolute filtering. Such a transfer process in aseptic conditions is lengthy and demanding to implement, since it requires in particular application of considerable precautions in order to ensure that adequate sterile conditions are maintained in the enclosure, such that nothing is introduced which can constitute a source of microbial contamination of the product during its transfer from one container to the other. The cost of purchasing systems of this type, and the costs of consumables, are also high.
Aseptic connectors for application to sterile solutions which do not require a controlled environment have also been proposed in the prior art. However, these connectors do not permit transfer of fluid products of all types, in particular viscous products, with a high flow rate of more than 15 kg/hour. They are therefore not at all suitable for a context of industrial production and packaging of large quantities of sterile products. Finally, they are single-use.